MAUDE Adverse Event Report: ALPHATEC SPINE, INC. IDENTITI ALIF STANDALONE INTERBODY SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/17/2022

Event Type  Injury  

Event Description

Around 10 months postoperative, radiographs revealed an identiti alif graft bolt backed out.It was reported this occurred following a fall the patient had a few months ago.

Manufacturer Narrative

The implant remains in-situ.The identifying part and lot number was not provided; therefore, a review of the device history records could not be performed.The root cause could not be determined at this time.If additional information is received, a supplemental report will be submitted.

Manufacturer Narrative

Corrected information: b1.Product problem, d4.Model# unknown, lot # unknown, udi # unknown , b6.Unknown, b7.Unknown , h1.Malfunction, h6.Type of investigation: 4117.Additional information: d5.Health professional.H6: investigation findings: 3221.Investigation conclusion: 4315.H10.The graft bolt is a component of the alphatec identiti alif standalone interbody system, which is an integrated intervertebral body fusion device for use in anterior lumbar interbody fusion (alif) procedures used in patients for treatment, not diagnosis.The implant remains in the patient.There was no report of revision surgery.Postoperative radiograph images were not provided to alphatec.Neither the identifying part nor lot number were provided.The patient's bone quality, medical history, and postoperative physical activity is unknown.It is unknown what postoperative instructions were provided to the patient prior or after surgery.Labeling review: possible adverse effects: possible adverse effects include: 1.Initial or delayed loosening, bending, dislocation, and/or breakage of device components.Postoperative management: postoperative management by the surgeon is essential.This includes instructing, warning, and monitoring the compliance of the patient.1.Patient should be informed regarding the purpose and limitations of the implanted devices.2.The surgeon should instruct the patient regarding the amount and time frame after surgery of any weight bearing activity.The increased risk of bending, dislocation, and/or breakage of the implanted devices, as well as an undesired surgical result are consequences of any type of early or excessive weight bearing, vibratory motion, falls, jolts or other movements preventing proper healing and/or fusion development.Based on the information provided, a root cause cannot be determined.If additional information is made available, a supplemental report will be submitted.On -05-dec-2022, the fda sent alphatec additional information request for this mdr.Alphatec responded to the fda on 13-jan-2023.

• Brand Name: IDENTITI ALIF STANDALONE INTERBODY SYSTEM
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR
• Manufacturer (Section D): ALPHATEC SPINE, INC.; 1950 camino vida roble; carlsbad CA 92008
• Manufacturer Contact: wesley channell ; 1950 camino vida roble; carlsbad, CA 92008 ; 9014283693
• MDR Report Key: 14131811
• MDR Text Key: 289429621
• Report Number: 2027467-2022-00016
• Device Sequence Number: 1
• Product Code: OVD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K203742
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other